With the implementation of GMP specifications and the development of the pharmaceutical industry, nitrogen is increasingly used in pharmaceutical production, and its quality requirements are becoming more stringent. In modern pharmaceutical technology, nitrogen is no longer an ordinary gas, but plays an important protective role that directly affects the quality and safety of pharmaceuticals.

In the drug synthesis process, high-purity nitrogen is needed to provide an inert atmosphere; in the biological fermentation process, pure nitrogen is needed for isolation; in the preparation filling process, nitrogen charging is needed to eliminate oxygen. For these application scenarios, medicinal nitrogen needs to meet the following quality parameters:

  1. The purity of nitrogen reaches over 99.999%, achieving an oxygen-free grade;
  2. Does not contain dust pyrogens, and the microbial content is less than 1CFU/m3;
  3. It can provide a stable air supply and ensure a continuous and stable production process.

Only high-quality pharmaceutical nitrogen that meets the above indicators can provide safe and reliable atmosphere protection for key pharmaceutical processes such as synthesis reactions, fermentation culture, and aseptic filling, thereby truly ensuring pharmaceutical quality.

The nitrogen generator ensures that the overall process of sterile pharmaceutical production meets quality standards by providing a high-purity nitrogen environment. Specifically:

Synthesis Reaction

The main functions of medicinal nitrogen generators in drug synthesis reactions are as follows:

  1. Provide an inert atmosphere: The synthesis reaction needs to be carried out under conditions where oxygen is removed. Nitrogen can provide an inert atmosphere to isolate the impact of oxygen on the reaction.
  2. Stirring and protection: Passing in medicinal high-purity nitrogen can fully stir and protect the reaction solution, improve the mixing effect and prevent the entry of impurities.
  3. Control the reaction rate: Adjusting the nitrogen concentration in the reactor can control the reaction rate to optimize yield and selectivity.
  4. Provide pressure: Some synthesis reactions need to be carried out under a certain pressure, and nitrogen can be used to provide a pressure environment.
  5. Safety protection: In organic synthesis, nitrogen can dilute the flammable gas in the reaction system and reduce the risk of combustion or explosion.
  6. Product drying: After the reaction, the inertness and drying characteristics of nitrogen can be used to dry the product.
  7. Equipment cleaning: Use nitrogen to clean reaction equipment to avoid contamination.

The medicinal nitrogen generator provides a safe, stable, and controllable nitrogen atmosphere for drug synthesis, and plays a key role in the entire synthesis process.

Fermentation Culture

The main functions of the medicinal nitrogen generator in the pharmaceutical fermentation and culture process are as follows:

  1. Provide sterile gas source: Fermentation has extremely high requirements on sterile conditions, and medicinal nitrogen can provide a clean gas source to reduce pollution.
  2. Adjust dissolved oxygen: Controlling the nitrogen concentration in the fermentation tank can adjust the dissolved oxygen content and optimize the growth environment of microorganisms.
  3. Stirring and mixing: The introduction of nitrogen can stir the fermentation liquid and improve the transfer of nutrients.
  4. Anti-foaming and defoaming: Injecting a certain amount of nitrogen can prevent excessive foam during the fermentation process, and can also be used to break excessive foam.
  5. CO2 removal: CO2 produced during the fermentation process can be removed in time through nitrogen purging.
  6. Filling and handling: Filling and handling of fermentation broth can be carried out under sterile conditions using nitrogen.
  7. Equipment cleaning and disinfection: Pre-filling and cleaning of fermentation tanks, etc. can be carried out using high-purity nitrogen.

The medicinal nitrogen generator provides a sterile and controllable nitrogen environment for fermentation, which is crucial to obtaining high-quality fermentation products.

Aseptic Filling

The main functions of the medicinal nitrogen generator in the aseptic filling process of pharmaceuticals are as follows:

  1. Provide a sterile atmosphere: Using medicinal high-purity nitrogen to fill the filling workshop with nitrogen can provide a sterile working environment.
  2. Product filling: Filling pharmaceuticals in a nitrogen environment can prevent products from being contaminated by air and microorganisms.
  3. Container purging: Use nitrogen to purge pre-filling containers such as glass bottles and plastic bottles to remove particles and microorganisms.
  4. Sealing test: Nitrogen gas can be used to test the sealing of the container to check whether there are micro leaks.
  5. Equipment flushing: Nitrogen can be used to aseptically flush the filling machine and pipelines to avoid cross-contamination.
  6. Handling protection: The use of nitrogen can protect the quality of filled drugs during transfer and handling.
  7. Personnel protection: Provide nitrogen dispersion for operators to reduce direct contact with air.

The pharmaceutical nitrogen generator ensures that the overall process of sterile pharmaceutical filling and packaging meets quality standards by providing a high-purity nitrogen environment.

Technical indicators of medicinal nitrogen generator

The main technical indicators of the medical nitrogen generator are as follows:

Nitrogen flow: 5-12000 m3/h (20°C, 101.325kPa)

Nitrogen purity: ≥97-99.9995% (can be customized)

Pressure dew point: ≤-45°C (can be customized)

Nitrogen pressure: 0.05-0.8MPa (can be customized)

Customers can choose a matching medicinal nitrogen generator model based on their specific requirements for nitrogen purity, flow rate and other parameters during their process. As long as they can provide personalized nitrogen solutions, manufacturers will customize and produce nitrogen production equipment suitable for their processes and production environments.